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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Kerecis® SurgiClose® Silicone - 05694310965163

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-surgiclose-silicone/
KERECIS hf.
10 x 18 cm fish skin
In Commercial Distribution

  • 05694310965170 ()
  • 05694310965163 ()

  • Height: 10 Centimeter
  • Width: 18 Centimeter
50214F56D0D

  • Collagen wound matrix dressing

Kerecis® SurgiClose® Silicone - 05694310965149

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-surgiclose-silicone/
KERECIS hf.
6 x 14 cm fish skin
In Commercial Distribution

  • 05694310965156 ()
  • 05694310965149 ()

  • Width: 14 Centimeter
  • Height: 6 Centimeter
50214F55D0D

  • Collagen wound matrix dressing

Kerecis® Shield™ Spiral - 05694310964364

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Spiral is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/
KERECIS hf.
Diameter: 30mm
In Commercial Distribution

  • 05694310964371 ()
  • 05694310964364 ()

  • Outer Diameter: 30 Millimeter
50215K52B0D

  • Collagen wound matrix dressing

Kerecis® Shield™ Standard - 05694310964319

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Standard is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/
KERECIS hf.
Diameter: 50mm
In Commercial Distribution

  • 05694310964326 ()
  • 05694310964319 ()

  • Outer Diameter: 50 Millimeter
50215I53B0D

  • Collagen wound matrix dressing

Kerecis® Shield™ Adhesive - 05694310963770

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Adhesive is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/
KERECIS hf.
30 mm Circular
In Commercial Distribution

  • 05694310963787 ()
  • 05694310963770 ()

  • Outer Diameter: 30 Millimeter
50215I52B0D

  • Collagen wound matrix dressing

Kerecis® Shield™ Adhesive - 05694310963756

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Adhesive is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/
KERECIS hf.
20 mm Circular
In Commercial Distribution

  • 05694310963763 ()
  • 05694310963756 ()

  • Outer Diameter: 20 Millimeter
50215H51B0D

  • Collagen wound matrix dressing

Halo Systems - 05690977368965

Skull Pin 2-1/4in CT Sterl 6PK
OSSUR AMERICAS, INC.
522CS
Not in Commercial Distribution

  • 05690977368965 ()
522CS

  • Cervical spine immobilization head ring rod

Halo Systems - 05690977368958

Skull Pin 3in TI Sterl 5 PK
OSSUR AMERICAS, INC.
520V2S
Not in Commercial Distribution

  • 05690977368958 ()
520V2S

  • Cervical spine immobilization head ring rod

Halo Systems - 05690977368941

Skull Pin 2-1/4in TI Sterl 5PK
OSSUR AMERICAS, INC.
520TS
Not in Commercial Distribution

  • 05690977368941 ()
520TS

  • Cervical spine immobilization head ring rod

Halo Systems - 05690977368934

Skull Pin 3in TI Sterl 1PK
OSSUR AMERICAS, INC.
516V2S
Not in Commercial Distribution

  • 05690977368934 ()
516V2S

  • Cervical spine immobilization head ring rod

Halo Systems - 05690977343306

CB RING TRAY LG
OSSUR AMERICAS, INC.
555CB
Not in Commercial Distribution

  • 05690977343306 ()
555CB

  • Cervical spine immobilization head ring

Halo Systems - 05690977343283

CB RING TRAY STD
OSSUR AMERICAS, INC.
554CB
Not in Commercial Distribution

  • 05690977343283 ()
554CB

  • Cervical spine immobilization head ring

Halo Systems - 05690977343269

CB RING TRAY SM
OSSUR AMERICAS, INC.
553CB
Not in Commercial Distribution

  • 05690977343269 ()
553CB

  • Cervical spine immobilization head ring

Halo Systems - 05690977334960

CB RING KIT TI SM-No App
OSSUR AMERICAS, INC.
515300T
Not in Commercial Distribution

  • 05690977334960 ()
515300T

  • Cervical spine immobilization head ring

Halo Systems - 05690977326200

CB RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500T
Not in Commercial Distribution

  • 05690977326200 ()
515500T

  • Cervical spine immobilization head ring

Halo Systems - 05690977319035

CB RING KIT TI STD-No App
OSSUR AMERICAS, INC.
515400T
Not in Commercial Distribution

  • 05690977319035 ()
515400T

  • Cervical spine immobilization head ring

Halo Systems - 05690977309357

Kit Closed Back Halo Lg
OSSUR AMERICAS, INC.
505501C
Not in Commercial Distribution

  • 05690977309357 ()
505501C

  • Cervical spine immobilization head ring

Halo Systems - 05690977309340

Kit Closed Back Halo Sm
OSSUR AMERICAS, INC.
505301C
Not in Commercial Distribution

  • 05690977309340 ()
505301C

  • Cervical spine immobilization head ring

Halo Systems - 05690977309333

Kit Closed Back Halo Md
OSSUR AMERICAS, INC.
505401C
Not in Commercial Distribution

  • 05690977309333 ()
505401C

  • Cervical spine immobilization head ring

Halo Systems - 05690977308695

OB V2 RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500V2
Not in Commercial Distribution

  • 05690977308695 ()
515500V2

  • Cervical spine immobilization head ring
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